Clinical trials: Digestive Infection
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic…
- Trial name
- NCT02671500
- Testing
- SOF/VEL
- Where
- 38 sites in China, Malaysia and 3 more
- Volunteers
- 375 people
- Sponsor
- Gilead Sciences
Liver Fibrosis, Hepatitis C
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Trial name
- NCT01707472
- Testing
- Simtuzumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who…
- Trial name
- START 4 (NCT01606800)
- Testing
- PEG-IFN alfa-2b, ribavirin
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
- Trial name
- NCT04454567
- Testing
- ABI-H0731, NrtI
- Where
- 12 sites in United States, Hong Kong and 1 more
- Volunteers
- 2 people
- Sponsor
- Assembly Biosciences
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic Hepatitis C
Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)
The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved…
- Trial name
- @dhere (NCT00704964)
- Testing
- PegIntron, Rebetol
- Volunteers
- 746 people
- Sponsor
- Merck Sharp & Dohme LLC
Acellular Pertussis, Hepatitis B
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence…
- Conditions
- Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT01453998
- Testing
- Infanrix hexa, Prevenar 13, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, HIV Infections
Coaching for HCV and HIV
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment…
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Trial name
- NCT04314414
- Testing
- PRC brief motivational interview intervention, Phone contact
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Medical Center
Helicobacter Pylori Infection, Dyspepsia
ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H.
- Trial name
- ERADICATE Hp2 (NCT03198507)
- Testing
- RHB-105, Active Comparator
- Where
- 55 sites in United States
- Volunteers
- 455 people
- Sponsor
- RedHill Biopharma Limited
Chronic Hepatitis C Infection
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects…
- Trial name
- GIFT I (NCT02023099)
- Testing
- ABT-450/r/ABT-267
- Volunteers
- 363 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin…
- Trial name
- REAL (NCT02582658)
- Volunteers
- 173 people
- Sponsor
- AbbVie
Pseudomonas Aeruginosa Infection
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections.
- Trial name
- NCT01315678
- Testing
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Where
- 62 sites in Austria, Belgium and 16 more
- Volunteers
- 302 people
- Sponsor
- Insmed Incorporated
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.
- Trial name
- NCT02694393
- Testing
- sodium nitrite
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Schmidhofer, Mark, MD
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
Colorectal Cancer Screening
Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily.
- Trial name
- NCT04683744
- Testing
- Semi-structured interviews-Patients, Semi-structured interviews-Health system
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Indiana University
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Hepatitis B
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine…
- Trial name
- NCT00440531
- Testing
- Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), Comparator: ENGERIX-B™ (currently licensed product)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™
Each Sci-B-Vac™ lot to be released to the market is tested in comparison to a reference batch,which has to be tested in a human clinical trial. This study was conducted by SciVac Ltd.
- Trial name
- NCT04179786
- Testing
- Sci-B-Vac™
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
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